Technical Documents

PQM helps strengthen regulatory systems and increase the capacity of national quality control laboratories (NQCLs) to detect poor-quality medicines, while also helping improve manufacturers’ ability to produce quality-assured medicines. These documents describe the ways in which we approach our work, detail select accomplishments, and report on key activities:

Strengthening national regulatory systems and increasing laboratory capacity to detect poor-quality medicines

Integrating Medicines Quality Assurance into Universal Health Coverage Programming: A Path to Increasing Efficiency, Access, and Coverage (09/2019)
A well-functioning universal health coverage (UHC) system would ensure access to safe, effective, affordable, quality-assured essential medicines. Ensuring medicine quality is rarely discussed in UHC planning, despite its inherent importance to achieving UHC’s goal of all people obtaining the health services they need without suffering financial hardship when paying for them. This white paper demonstrates the benefit of ensuring medicine quality in UHC, examines the association between UHC and medicine quality in the context of essential medicines in low- and middle-income countries, assesses the health and economic impact of poor-quality antimalarials in a case study, and provides recommendations to integrate medicines quality assurance into UHC programming.
Strengthening Medical Product Quality Assurance Systems in Ethiopia: Progress on the Path to Self-Reliance (8/2019)
This brief summarizes how the PQM program supported the Ethiopian Food, Medicine and Health Care Administration and Control Authority (EFMHACA) to strengthen in-country medical product quality assurance systems, including improving quality control testing, equipment maintenance, and post-marketing surveillance.
Strengthening Regulatory Systems to Improve Medical Product Quality in Low- and Middle-Income Countries (9/2018)
This document reviews key regulatory challenges in low- and middle-income countries, the key areas in which PQM aims to build or strengthen regulatory capacity, and shares lessons learned from the program’s extensive implementation experience. Strengthening the capacity of medicines regulation authorities requires in-depth and ongoing consideration of the broader country context and health system components that interact and influence operations. As such, PQM relies on strategies and interventions rooted in systems thinking to sustainably strengthen regulatory capacity.
Strengthening Indonesia’s Pharmaceutical Post-Marketing Surveillance Capacity (9/2018)
This brief summarizes how the PQM program supported Indonesia’s Ministry of Health and the National Agency for Drug and Food Control to improve intra-government communication and develop regulations to ensure that a robust quality assurance system was not only in place but also being implemented across the public and private sectors.
Building Foundations for Robust Quality Assurance Systems in Myanmar (9/2018)
This brief summarizes how the PQM program used its systems-strengthening approach to support the Government of Myanmar in building capacity to properly ensure the quality of antimalarial medicines, with major focus on improving capacity within the country’s network of Quality Control laboratories to accurately and reliably test the quality of medicines and, ultimately, achieve ISO accreditation.
A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries (6/2018)
This document proposes a framework to assist medicines regulatory authorities in lower- and middle-income countries in managing and sustainably supporting pharmaceutical quality assurance to achieve maximum health impact and efficiencies. The framework is specifically intended as a guide for the development of country-specific resource allocation tools, and consists of six core elements: (1) risk analysis, (2) analysis of the pharmaceutical market, (3) analysis of country characteristics, (4) assessment of the regulatory and quality assurance environment, (5) risk management, and (6) assessment of the impact of resource allocation.
Guidance for Implementing Risk-Based Post-Marketing Quality Surveillance in Low- and Middle-Income Countries (2/2018)
Strong national post-marketing surveillance programs capable of monitoring the overall quality of medical products (e.g., medicines, vaccines, devices, and diagnostic kits) and responding to public health risks can help protect populations from the threats posed by substandard and falsified medicines. The PQM program, through extensive consultation with international experts, has developed this document to guide the implementation of comprehensive risk-based post-marketing surveillance programs in low- and middle-income countries.
Strengthening National Quality Control Laboratories in Low- and Middle-Income Countries to Improve the Quality of Medicines (2/2018)
The document describes PQM’s technical approach to building the managerial and technical capabilities of national quality control laboratories to strengthen local capacity to detect substandard and falsified medicines. This approach has guided PQM in supporting national quality control laboratories to develop stronger laboratory quality management systems, comprehensive laboratory quality assurance policies and practices, medium- and long-term instrument maintenance plans, and risk-based sampling and testing activities.
Analytical Instrumentation Support for National Quality Control Laboratories (2/2018)
This document outlines PQM’s approach to supporting national quality control laboratories in managing and maintaining their analytical instrumentation and outlines strategies for building in-house expertise of laboratory staff, strengthening the capacity of national metrology institutes, and strategically partnering with contract service providers to share resources and calibration reference standards.
Strengthening national capacity in medicines quality: five-year summary 2005–2009, Promoting the Quality of Medicines program in Southeast Asia and the Philippines (3/2010)
Ensuring the quality of medicines in resource-limited countries: an operational guide (2007)

Increase the supply of quality-assured medicines

GSK Chlorhexidine Digluconate (7.1%) Gel Technology Transfer Report (5/2019)
This technology transfer report is intended to serve as a guidance document on the development and manufacture of Chlorhexidine (CHX) gel. The report addresses the development of the formulation, including analytical testing along with manufacturing and primary packaging processes. The report also provides guidance for the commercial manufacturing and primary packaging of CHX gel into 3g sachets.
Revisiting the Stability and Storage Specifications of Oxytocin Injection: A Literature Review (7/2018)
Strengthening Manufacturing Capacity to Improve Access to Quality-Assured Essential Medicines (12/2017)
PQM works to strengthen the capacity of pharmaceutical manufacturers to produce quality-assured medicines and collaborates with manufacturers globally to address critical shortages or gaps in the supply of essential medicines. This technical report describes the support PQM provides to manufacturers and the technical approach employed.
Production of zinc tablets and zinc oral solutions: guidelines for programme managers and pharmaceutical manufacturers (2007)

Technical Documents

Strengthening national regulatory systems and increasing laboratory capacity to detect poor-quality medicines

Increase the supply of quality-assured medicines

Collection and utilization of medical product quality information to increase evidence-based decision-making

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